Director - Process Development, Downstream & Upstream

Catalent•Madison, WI

1d•Onsite

About The Position

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. The approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem. We have an opportunity for a Director, Process Development to join our team and lead the Process Development organization. This role is responsible for advancing biologics process development from early-phase programs through commercial readiness while ensuring successful transfer into manufacturing. You will deliver scalable upstream and downstream processes, support manufacturing execution, and align cross-functional teams and clients to meet development timelines and business objectives. This position provides technical, operational, and people leadership across multiple functions and sites, driving strategic initiatives, process improvements, and organizational performance.

Requirements

Bachelor’s degree in a STEM discipline and 15+ years related experience.
OR Master’s degree in a STEM discipline and 12+ years related experience.
OR Doctorate degree in a STEM discipline and 8+ years related experience.
6+ years of leadership experience.
Deep understanding of biologics process development and manufacturing.
Experience in drug development and lifecycle support.
Excellent written and verbal communication skills.
Ability to communicate complex technical information to non-technical audiences.

Nice To Haves

Experience leading multi-site strategic initiatives.
Expertise in mammalian cell culture and upstream process development.
Expertise in downstream process development and process characterization.
Experience supporting technology transfer and commercial manufacturing readiness.
Strong stakeholder management and executive influence skills.
Ability to manage multiple priorities across sites and functions.
Experience with process optimization and continuous improvement initiatives.
Strong coaching, mentoring, and talent development capabilities.
Experience leading customer-facing technical discussions and issue resolution.
Experience supporting production in single-use bioreactor environments.

Responsibilities

Lead Process Development teams and manage 2–10 direct reports.
Define and execute department strategy based on scientific and business priorities.
Oversee development of scalable expression, purification, and product quality processes.
Support manufacturing through process transfer, technology transfer, investigations, and facility fit assessments.
Partner with clients, project management, and leadership to meet timelines and expectations.
Lead cross-functional and multi-site strategic initiatives and process improvement efforts.